BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIGHTHAWK DIAGNOSTIC CATHETER

    MDR report key: 173331 · Received June 17, 1998

    Report

    Report Number
    6000058-1998-00022
    Event Type
    Injury
    Date Received
    June 17, 1998
    Report Date
    June 12, 1998
    Manufacturer
    MEDI-TECH A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID DIAGNOSTIC PROCEDURE, THE PT SUFFERED A STROKE. HOSPITAL STAFF UNSUCCESSFULLY ATTEMPTED TO DISSOLVE CLOT. THE PT IS SUFFERING FROM LEFT SIDE PARALYSIS AND STATUS IS LISTED AS CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIGHTHAWK DIAGNOSTIC CATHETER DIAGNOSTIC CATHETER DQO MEDI-TECH A DIV OF BOSTON SCIENTIFIC CORP NHTS/5/SIM2/038/100/NS BX/5 1256763

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention